Effects of Electromechanical Gait Trainer in Patients With Multiple Sc
Effects of Electromechanical Gait Trainer on Endurance, Fatigue and Daily Life Autonomy in Patients With Multiple Sclerosis: a Randomized Control Trial
What it found
We found no results in the registry or in papers.
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Gait trainer treatment
Placebo
- Conventional treatment
What it measured
Main measures
6-minute Walking Test
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.
Walking and mobility
Other measures (6)
10-meter Walking Test
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Walking and mobilityFalls efficacy scale score
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
FatigueWalking and mobilitySpatio-temporal gait analysis
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Walking and mobilityStatic balance assessment
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Walking and mobilityMeasure of energy cost
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Hamilton Rating Scale for Depression
All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Mood and sleep
Who could take part
Relapsing MS · 30 to 60
Show the full criteria
Inclusion criteria
1. age between 30 and 60 years 2. Expanded Disability Status Scale (EDSS) score 2.0≥ x ≤ 4.0 3. Mini Mental State Evaluation (MMSE) score ≥ 24 4. absence of heart problems 5. ability to maintain standing position without aids for at least 1 minute 6. ability to walk independently for at least 15 metres 7. absence of concurrent neurological or orthopaedic diseases that interfere with deambulation.
Exclusion criteria
1. disease recurrence that worsens significantly during the 3 months prior to recruitment 2. pharmacological therapy not well defined 3. performance of any type of rehabilitation treatment in the month prior to recruitment 4. presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple Sclerosis is a very disabling disorder in young adult patients leading to an important limitation in daily life activities and social participation. Among of the different causes of disability in MS patients gait impairments, fatigue and balance disorders can be considered as the main concerns. Thus, gait restoration in patients with MS is the one of the primary objective of rehabilitation and often influences whether a patient can return home or to work. Even if potentially innovative treatments like treadmill training have been proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been extensively studied in patients with MS.
Papers
Background
Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.Background
Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.Background
Benedetti MG, Gasparroni V, Stecchi S, Zilioli R, Straudi S, Piperno R. Treadmill exercise in early mutiple sclerosis: a case series study. Eur J Phys Rehabil Med. 2009 Mar;45(1):53-9.
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History
Started
Nov 2011
Main results due
Feb 2012
Finished
Dec 2012